Cleared Traditional

K955760 - TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

K955760 is an FDA 510(k) clearance for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM, manufactured by Bayer Corp.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K955760 · Bayer Corp. · Microbiology device
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Aug 1996
Decision
226d
Days
Class 2
Risk

K955760 is an FDA 510(k) clearance for the TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on August 2, 1996 after a review of 226 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Corp. devices

FDA 510(k) Submission Details - K955760

510(k) Number K955760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1995
Decision Date August 02, 1996
Days to Decision 226 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 102d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGD Device Classification - Class 2, Special Controls

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 95
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K955760.
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · Incstar Corp. · Dec 1996
AXSYM TOXO IGM
K954576 · Abbott Laboratories · Aug 1996
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
SERAQUEST TOXOPLASMA IGG
K960092 · Quest Intl., Inc. · Jun 1996
TOXOSTAT
K944867 · Bio-Whittaker, Inc., A Cambrex Co. · May 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp. · Feb 1996